Patients with seasonal allergic rhinitis to grass pollen MedDRA version: 14.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Alutard SQ Phleum pratense grass pollen allergen extract
Product Name: Alutard SQ Phleum pratense
Product Code: Alutard SQ
Pharmaceutical Form: Oral drops, suspension
Trade Name: Grazax
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female 18-65 years of age Written informed consent obtained before entering the trial A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season Positive Skin Prick Test (SPT) response (wheal diameter = 3 mm) to Phleum pratense Positive specific IgE against Phleum pratense (= IgE Class 2) Physical examination with no clinically relevant findings If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial Willingness to comply with this protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of – and potentially overlapping - the grass pollen season A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed History of emergency visit or admission for asthma in the previous 12 months Use of an investigational drug within 30 days prior to screening Previous treatment by immunotherapy with grass pollen allergen within the previous 10 years History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis History of angioedema Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alcoholism Ischemic heart disease or angina requiring current daily medication Or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease) Immunosuppressive treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U. ;Secondary Objective: To evaluate the safety of the three different formulations by assessing adverse events recorded daily by the patient. ;Primary end point(s): To evaluate the immunological response in subjects with grass pollen induced allergic rhinoconjunctivitis after 8 weeks of once daily dosing with sublingual immunotherapy, either Alutard SQ Phleum pratense, 25,000 SQ-U, ALK Grass tablet Phleum pratense 25,000 SQ-T, or Aquagen Phleum pratense, 25,000 SQ-U. | — |
Countries
United Kingdom
Outcome results
None listed